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www.fdanews.com/articles/91178-sanofi-aventis-acomplia-wins-reimbursement-in-france

Sanofi-Aventis' Acomplia Wins Reimbursement in France

March 22, 2007

Sanofi-aventis announced that its weight-loss drug Acomplia has been added to the list of pharmaceutical products that are reimbursable under the French health system, as published in the Official Journal of the French Republic.

The drug is now reimbursable in France for obese patients (those with body mass indexes equal to or greater than 30 kg/m2) whose Type 2 diabetes is uncontrolled by monotherapy with metformin or a sulphonylurea and whose HbA1c is in the range of 6.5 percent to 10 percent. According to the treatment guidelines, Acomplia (rimonabant) should be an adjunct to diet and physical activity.

For qualified patients, Acomplia has two benefits: a reduction in weight and waist circumference and an improvement of the glucose and lipid metabolism, sanofi-aventis said.

There is no alternative to Acomplia on France's list of reimbursable drugs, the company added. The drug will be available at a price of 71.63 euros for a 28-day course.

Acomplia is a selective cannabinoid-1 receptor antagonist and the first drug in this new therapeutic class, according to the company. The drug won approval in the European Union in June 2006. The application for Acomplia in the U.S. is still being considered.

German regulators have decided to classify Acomplia as a non-reimbursable, or lifestyle, drug. Sweden, Denmark and Ireland have decided in favor of reimbursing the drug for treating obesity in diabetes patients.